COVAXIN: Phase-I trial of the Bharat Biotech’s Vaccine shows no serious adverse effect

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The phase 1 clinical trial findings of Bharat Biotech’s COVID-19 vaccine “COVAXIN” has revealed no serious adverse effects, said the interim report.

Around 375 participants were enrolled in the first phase clinical trials; of Bharat Biotech’s COVAXIN, of which, only one person had shown side effects, that too was not; reported because of the vaccine doses, whereas, 75 volunteers received the placebo.

One of the participants was administered the vaccine on 30th July, but he was tested COVID-19 positive five days later. He was then hospitalized on 15th August and was discharged after a week. However, this is not seen in relation to the vaccine.

On the other hand, some participants said they had felt pain; at the injection site, which resolved in a few days. The vaccine was reportedly stored between 2 degrees Celsius and 8 degrees Celsius.

The COVAXIN researchers are also likely to send the study to “The Lancet” journal. Earlier on 16th November, Bharat Biotech had announced the commencement of Phase III trials of its corona virus vaccine and said that it will involve 26,000 volunteers across India.

COVAXIN: Phase-I trial of the Bharat Biotech’s Vaccine shows no serious adverse effect
The Indian Express

The Genome Valley-based company had said in an official statement that “It is the largest clinical trial conducted; for a COVID-19 vaccine in India. This is India’s first phase 3 efficacy study for a COVID-19 vaccine, and the longest phase III efficacy trial; ever conducted in India.”

The company was the talk of the town recently when the Haryana minister Anil Vij said that he has contracted COVID-19, 15 days after taking a corona virus vaccine shot.

Subsequently, Bharat Biotech issued a clarification on 5th December saying that the efficacy of the vaccine can only be determined 14 days after the second dose.

Bharat Biotech further informed that the Phase-III trials are; double-blinded and randomised, where 50 per cent of the subjects will receive the vaccine and 50 per cent will receive a placebo.

The Health Ministry too came out in support of the drug company; and asserted that Vij had only taken one dose of the two-dose vaccine; and so he contracted COVID-19.

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